Smart Finance learned on July 30 that the General Office of the Shanghai Municipal People's Government issued several opinions on supporting the innovative development of the entire chain of the biomedical industry. Among them, it was proposed to support artificial intelligence technology to empower drug research and development. Fully utilize generative AI, deep learning and other technologies, focus on new drug target mining and verification, drug discovery and design, new drug screening, medication safety analysis and other links, accelerate model, algorithm, professional software and other research breakthroughs and common platform construction, and carry out intelligent scene application demonstration.

Continuously increase support for innovative drug research and development. For new drugs of category 1 that are registered and applied for clinical trials in phases I, II, and III by applicants registered in our city and achieve output, according to regulations, they will be given support not exceeding 40% of R&D investment, with the highest support of 10 million yuan, 20 million yuan, and 30 million yuan respectively for different stages; for cell and gene therapy new drugs of category 1 that only need to complete early clinical trials and confirmatory clinical trials, according to regulations, the highest support of 15 million yuan and 30 million yuan will be given in priority. The cumulatively supported amount of each unit per year is up to 0.1 billion yuan.

Original text:

Several Opinions of the General Office of the Shanghai Municipal People's Government on Supporting the Innovative Development of the Biomedical Industry throughout the Entire Chain

Shanghai Municipal Government Office Regulation [2024] No. 9

To the people's governments of all districts, committees, bureaus under the municipal government:

Developing the biomedical industry is an important tool for accelerating the formation of new productive forces. In order to further build a major strategic industry highland for global biomedical industry in the new era, support high-quality economic and social development in the whole city, and make suggestions on supporting the innovation and development of the entire chain of biomedical industry, the following opinions are proposed:

First, vigorously enhance innovation capacity

(1) Accelerate basic theoretical innovation and frontier technology breakthroughs. Give full play to the role of innovation platforms such as national strategic science and technology forces, target basic and frontier fields and new tracks such as cell and gene therapy, mRNA, synthetic biology, and regenerative medicine, carry out new target, new mechanism, new structure research, layout frontier new technologies and new drug research. Strengthen high-end medical equipment, advanced pharmaceutical equipment and materials, and modern traditional Chinese medicine research and development. (Responsible unit: Municipal Science and Technology Commission, Municipal Development and Reform Commission)

(2) Support artificial intelligence technology to empower drug research and development. Fully utilize generative AI, deep learning and other technologies, focus on new drug target mining and verification, drug discovery and design, new drug screening, medication safety analysis and other links, accelerate model, algorithm, professional software and other research breakthroughs and common platform construction, and carry out intelligent scene application demonstration. (Responsible unit: Municipal Science and Technology Commission, Municipal Economic and Informationization Commission, Municipal Development and Reform Commission)

(3) Support top scientists and excellent young talent projects. Support world-class scientists and master-level personnel with core intellectual property (IP) to carry out subversive theoretical and technical breakthroughs in Shanghai in accordance with the principle of "one matter, one discussion." In terms of basic research pilot zones, various talent plans, etc., support excellent young talents in priority. (Responsible unit: Municipal Talent Bureau, Municipal Science and Technology Commission, Municipal Economic and Informationization Commission)

(4) Accelerate the transformation of scientific research results to preclinical research. Establish a favorable interest rate support mechanism with drug clinical trial batch application volume, local transformation output volume and other targets as the assessment targets, and promote contract research organizations (CROs) to provide preclinical research services for new drugs to colleges and research institutions, giving up to 10 million yuan in support for each project annually in accordance with regulations. Encourage enterprises to take the lead in carrying out the construction of multi-subject full-chain innovation conversion joint bodies. (Responsible units: Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Finance Bureau)

(5) Continuously increase support for innovative drug research and development. For new drugs of category 1 that are registered and applied for clinical trials in phases I, II, and III by applicants registered in our city and achieve output, according to regulations, they will be given support not exceeding 40% of R&D investment, with the highest support of 10 million yuan, 20 million yuan, and 30 million yuan respectively for different stages; for cell and gene therapy new drugs of category 1 that only need to complete early clinical trials and confirmatory clinical trials, according to regulations, the highest support of 15 million yuan and 30 million yuan will be given in priority. The cumulatively supported amount of each unit per year is up to 0.1 billion yuan. (Responsible units: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal Drug Administration, Municipal Finance Bureau)

(6) Continuously increase support for the development of innovative medical instruments. For products that have entered the special review procedure for innovative medical instruments of the state and our city, the maximum support of 3 million yuan will be given in accordance with regulations; for the products that have obtained the registration certificate for the first time and landed in production, the maximum support not exceeding 40% of R&D investment and up to 8 million yuan will be given in accordance with regulations. The cumulatively supported amount of each unit per year is up to 30 million yuan. (Responsible units: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal Drug Administration, Municipal Finance Bureau)

Second, promote the better endowment of clinical resources for industrial development

(VII) Support the construction of research-oriented hospitals. Promote the construction of Shanghai Clinical Research Center. Promote the transformation and development of high-level hospitals with clinical innovation research activities as their main function to research-oriented hospitals with conditions. Encourage the setting of research beds according to 10% of the approved beds, and build research wards with complete functions and intensive sharing. Encourage social capital to build research-oriented hospitals. (Responsible Units: Municipal Health Commission, Shenkang Hospital Development Center, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Finance Bureau)

(VIII) Optimize and improve the mechanism for clinical achievement transformation. Give full play to the role of Shanghai Clinical Innovation Transformation Research Institute, allow hospitals to entrust the equity formed by the valuation of intangible assets into the institute and obtain corresponding equity income. Implement the third round of the 'Three-year Action Plan to Promote Clinical Skills and Innovation of Municipal Hospitals', support high-level hospitals to carry out medical innovation and achievement transformation, and support research-oriented hospitals with conditions to initiate high-level clinical research. (Responsible Units: Shenkang Hospital Development Center, Municipal Health Commission, Municipal Science and Technology Commission, Municipal State-owned Assets Supervision and Administration Commission, Municipal Finance Bureau)

(IX) Shorten the start-up time of clinical trials. Coordinate and integrate health and medical data throughout the city to build related queue basic information libraries, build high-quality and high-level biological sample libraries and management standard systems. Establish preparatory queues for clinical trials of major diseases such as tumors, cardiovascular and cerebrovascular diseases, metabolism, and psychiatric and neurological diseases to support the rapid inclusion of subjects. Strive to compress the overall internal time for medical institutions before the start of clinical trials to within 25 weeks. (Responsible Units: Municipal Health Commission, Shenkang Hospital Development Center, Municipal Data Bureau, Municipal Science and Technology Commission, Municipal Finance Bureau)

(X) Improve the efficiency of medical ethics review. Establish the working mechanism of 'one set of materials, one submission' for ethics review, and carry out project management department pre-review, ethics formal review, and contract pre-review procedures in parallel. Improve the efficiency and frequency of ethics review meetings; the leading unit (main review unit) should conduct the review and issue opinions within 15 working days after acceptance, and the participating units using the simple review process should conduct the review and issue opinions within 5 working days after acceptance, striving to compress the overall flow time of ethics review to within 3 weeks. Encourage participating institutions in multi-center clinical research to actively recognize the ethics review results of the leading institution, and continue to promote mutual recognition of medical ethics review results in the city. (Responsible Units: Municipal Health Commission, Municipal Drug Administration, Shenkang Hospital Development Center)

(XI) Establish incentive mechanisms for clinical trial teams of medical institutions. Promote medical institutions to improve the compensation and distribution mechanism of clinical trial teams, support the use of clinical research work and its results as important references for job title evaluation, job competition, and performance appraisal, and allow clinical trial-hosting projects that meet the conditions to be regarded as municipal scientific research projects. (Responsible Units: Municipal Health Commission, Municipal Human Resources and Social Security Bureau, Municipal Science and Technology Commission, Shenkang Hospital Development Center)

(XII) Connect with international standards to carry out high-level clinical trial projects. Support qualified contract research organizations (CROs) to connect with international standards to carry out projects to improve clinical trial service capabilities, and give the highest support of up to 1 million yuan to each project according to the regulations. For high-level innovative product clinical trial projects conducted overseas, give the highest support of up to 20 million yuan according to the regulations. The accumulative support for each unit shall not exceed 0.1 billion yuan per year. (Responsible Units: Municipal Science and Technology Commission, Municipal Drug Administration, Municipal Finance Bureau, Shenkang Hospital Development Center)

(XIII) Improve the clinical trial liability risk compensation mechanism. Encourage insurance institutions to develop domestic clinical trial and product liability insurance, overseas clinical trial and high-end medical equipment liability insurance, and give support of 50% of the actual premium paid according to the regulations, with a maximum of 0.5 million yuan and 1 million yuan, respectively, to insured enterprises. (Responsible Units: Municipal Science and Technology Commission, Shanghai Financial Regulatory Bureau, Municipal Drug Administration, Municipal Finance Bureau)

III. Promote further acceleration of review and approval

(XIV) Strive for national registration and evaluation support. Promote the implementation of national reform pilots, compress the time limit for drug supplementary application review and evaluation to 60 working days, and compress the time limit for drug clinical trial application review and approval to 30 working days. Support the improvement of the capacity of the Shanghai branch of the National Medical Products Administration in key areas such as product acceptance, review, and inspection. Speed up the research on the continuous manufacturing process rules. (Responsible Units: Municipal Drug Administration, Municipal Science and Technology Commission)

(XV) Strengthen pre-registration and evaluation guidance services. Focus on key research and development products and projects, implement special personnel and teams of the drug regulatory department to guide the process, and provide docking services for pre-clinical research, production license, market license, inspection and testing and other key links; implement pre-registration, full-process online processing, instant approval, intelligent evaluation and other measures, and give priority registration sampling and GMP compliance inspection to key research and development drugs; provide pre-pre-examination of declaration materials for key research and development of Class III medical devices and give priority to registration testing and other services. (Responsible Units: Municipal Drug Administration, Municipal Science and Technology Commission, Municipal Health Commission)

(XVI) Accelerate the registration and evaluation of Class II medical devices. For Class II medical devices with clear clinical value and strong innovation, encourage the application of special review procedure, prioritize registration inspection, technical evaluation and registration system verification; products that belong to the first in the country or meet the conditions for prioritized approval of medical equipment shall be implemented. The average time limit for the evaluation of Class II medical devices is compressed to within 40 working days. (Responsible Units: Municipal Drug Administration)

Improve the ability of drug and instrument registration and inspection services. Support the construction of professional technical service platforms for biological products, implantable medical devices, large medical equipment, and medical software, and provide enterprises with product safety evaluation, quality control, registration and record-keeping, risk assessment, inspection, testing and technical training services for the pharmaceutical and medical device inspection and testing agencies. (Responsible unit: Municipal Drug Administration Bureau, Municipal Science and Technology Committee, Municipal Development and Reform Commission)

Accelerate the promotion of innovative products

Encourage the use of innovative products in hospitals. Continuously update the 'New and Excellent Medical Devices' product catalog, open up a 'green channel' for innovative medical devices, and recommend inclusion in the national medical insurance drugs, 'Shanghai Huibao' and other catalog protection scope. Within one month of the update and release of national medical insurance drugs and 'new and excellent medical devices', our city's medical institutions will use corresponding innovative medical devices in accordance with the principle of 'should be equipped with all and must be equipped with the required'. Timely include eligible pharmacies in the 'dual channel' scope. Strengthen the innovative responsibility assessment of municipal hospitals, and medical institutions are not allowed to limit the admission of innovative medical devices due to the number of drugs used, drug/consumable ratio, etc. (Responsible unit: Municipal Science and Technology Committee, Municipal Medical Insurance Bureau, Municipal Health Commission, Shenkang Hospital Development Center, Shanghai Financial Regulatory Bureau)

Increase support for innovative products' medical insurance payments. For the diagnosis and treatment items involved in national medical insurance negotiated drugs and innovative medical devices, the medical insurance budget is implemented to pay separately in DRG/DIP reform; for innovative medical devices and innovative medical service projects with high value and meeting the conditions, they are independently grouped in DRG/DIP reform, and the payment standard is increased and not subject to the restriction of high magnification case number. Research and timely include the 'new and excellent medical devices' products that meet the regulations into the medical insurance payment scope. (Responsible unit: Municipal Medical Insurance Bureau, Municipal Health Commission, Municipal Drug Administration Bureau, Municipal Science and Technology Committee, Shenkang Hospital Development Center)

Support the demonstration application and promotion of innovative products. Support medical institutions and enterprises to carry out innovative medical device application demonstration projects, conduct post-market evaluation, real-world effectiveness evaluation, indication expansion research, and give each project the highest support of 2 million yuan according to regulations. Encourage the development of government procurement cooperation innovation in the field of biomedicine. (Responsible unit: Municipal Science and Technology Committee, Municipal Finance Bureau, Municipal Drug Administration Bureau, Shanghai Financial Regulatory Bureau, Municipal Health Commission, Municipal Medical Insurance Bureau, Shenkang Hospital Development Center)

Strengthening Services for Enterprises and Supporting Industrial Landing

Establish a mechanism to coordinate and solve the problems of enterprise development. Based on the working groups at the city and district levels, focusing on 100 key enterprises, 100 major investment projects, 100 key products, and 100 key pipelines, establish a coordination and problem-solving list system for the 'four 100' issues. Based on the Shanghai industrial medical financial integration strategy consulting committee, build a platform for exchanges among government, industry, academia, research and finance. (Responsible unit: Municipal Science and Technology Committee, Municipal Drug Administration Bureau, Municipal Health Commission, relevant district governments)

Cultivate heavy-weight products. Guide and support innovative products developed and produced in Shanghai, which have first-time breakthroughs in related output value and scale. Give full play to the role of state-owned investment funds, strengthen policies and support at the city and district levels, and encourage the expansion of related product market scale. (Responsible unit: Municipal Science and Technology Committee, Municipal Development and Reform Commission, Municipal State-owned Assets Supervision and Administration Commission, Municipal Finance Bureau, relevant district governments)

Accelerate the construction of major industrial projects. Support project construction such as process technology R&D, specialized technical service platforms, and industrialization bases, and give priority support up to 30% of the approved new investment according to regulations; encourage enterprises to accelerate high-end, intelligent, and green transformation, and give priority support of up to 10% of the approved total investment according to regulations, both of which have a maximum support of 100 million yuan. (Responsible unit: Municipal Science and Technology Committee, Municipal Economic and Information Commission, Municipal Development and Reform Commission)

Promote a new mode of contract R&D and production organization. Support contracted R&D and production organizations (CMO) that have mature production experience and production enterprises to undertake commissioned production activities (the commissioning parties should have no investment-related links), and give the entrusted parties support of no more than 10% of the annual production value of the entrusted year, with the highest support of 5 million yuan for each variety and the highest support of 10 million yuan for each enterprise per year. (Responsible unit: Municipal Science and Technology Committee, Municipal Drug Administration Bureau, Municipal Finance Bureau)

Strengthen industrial landing guarantees and linkage. Establish a city-district industrial coordination and linkage mechanism, strengthen city-level overall planning and scheduling, promote intra-district linkage, information sharing, and resource complementarity. Launch 5 million square meters of standardized biopharmaceutical factories, and support eligible projects to carry out 'industrial upstairs' activities. Encourage state-owned park management companies to carry out and strengthen investment and financing businesses, and weaken rental, profit and other performance indicators. (Responsible unit: Municipal Science and Technology Committee, Municipal Economic and Informationization Commission, Municipal State-owned Assets Supervision and Administration Commission, relevant district governments)

Strengthen Investment and Financing Support

Cultivate medium- and long-term investors and patient capital. Give full play to the role of the Shanghai biopharmaceutical industry mother fund, biopharmaceutical industry equity investment fund, and biopharmaceutical innovation transformation fund, and strengthen strategic relief investment for potential enterprises and high-quality research and development pipelines. Encourage the government to guide funds to 'invest early, invest small, and invest in hard technologies'. Research and establish a long-term project assessment and fault-tolerant mechanism for state-owned funds. (Responsible unit: Municipal State-owned Assets Supervision and Administration Commission, Municipal Development and Reform Commission, Municipal Science and Technology Committee, Municipal Finance Bureau, Municipal Committee's Financial Office)

Encourage the development of corporate venture capital (CVC). Support companies to establish CVC alone or in partnership to strengthen innovation incubation and promote synergy in the industrial chain. Provide support for CVCs that meet the criteria, including contributions from municipal state-owned assets and industry mother funds, and accelerated establishment of funds. (Responsibility Units: Municipal State-Owned Assets Commission, Municipal Economic and Informationization Commission, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Committee Financial Office)

Support companies to expand and strengthen through mergers and acquisitions. Set up a Shanghai biomedicine industry merger and acquisition fund to actively guide qualified biomedicine enterprises to initiate the establishment of merger and acquisition funds based on the needs of industrial transformation and upgrading to support companies to carry out merger and acquisition investments around the upstream and downstream of the industrial chain. (Responsibility Units: Municipal State-Owned Assets Commission, Municipal Science and Technology Commission, Municipal Committee Financial Office, Municipal Economic and Informationization Commission, Municipal Development and Reform Commission)

Broaden financing channels for companies in various forms. Strengthen credit support for enterprises through policy tools such as preferential interest rates, long-term loans, and interest subsidies for key industries. Give full play to the role of the municipal small and micro enterprise policy financing guarantee fund, and increase the single-batch guarantee limit for small and micro biological and medical science and technology enterprises to 20 million yuan. Increase the guarantee limit for medium-sized innovative biopharmaceutical science and technology enterprises with qualifications such as hi-tech, specialization, special and new, and science and technology giants to 30 million yuan. (Responsibility Units: Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Financial Bureau, Municipal Committee Financial Office, Shanghai Financial Regulatory Bureau)

Release the value of data element resources.

Establish a mechanism for chain research data open sharing. Promote the chaining of research data, provide data analysis services for medical and health institutions, scientific research institutes, and enterprises and institutions upon request relying on the Shanghai health and health data platform. Promote the sharing and use of data such as genes and cells among hospitals. Promote the construction of a real-world research information platform for rare diseases and pilot the establishment of a rare disease drug real-world research operation mechanism. (Responsibility Units: Municipal Health Commission, Municipal Data Administration, Municipal Science and Technology Commission, Shenkang Hospital Development Center)

Improve the cooperation and utilization mechanisms of medical and medical insurance data resources. Using technologies such as blockchain, privacy computing, and data space, relying on the Medical Insurance Big Data Innovation Laboratory, establish data cooperation and utilization mechanisms between hospitals, medical insurance and commercial insurance institutions, and pharmaceutical companies. Strengthen the application of data in the research and development of innovative drugs, clinical diagnosis and treatment, and commercial health insurance products, and accelerate the development of commercial health insurance products. (Responsibility Units: Municipal Medical Insurance Bureau, Shenkang Hospital Development Center, Municipal Health Commission, Municipal Data Administration, Shanghai Financial Regulatory Bureau)

Build high-quality corpora and industry data sets. Focusing on basic research, new drug development, medical services, and insurance product development, establish several high-quality artificial intelligence corpora and industry data sets. Support enterprises and institutions to carry out medical and health large-scale model training based on artificial intelligence data training facilities. (Responsibility Units: Municipal Economic and Informationization Commission, Municipal Development and Reform Commission, Municipal Data Administration, Municipal Health Commission, Municipal Medical Insurance Bureau, Shenkang Hospital Development Center)

Promote the safe and compliant flow of industry data. Establish a biomedicine zone in the Shanghai Data Exchange to promote the legal and compliant trading of medical and pharmaceutical patents, test data, and industry analysis data. Relying on the China (Shanghai) Pilot Free Trade Zone (hereinafter referred to as the "Shanghai FTZ") Lingang New Area to carry out pilot projects, support the cross-border safe and compliant flow of biopharmaceutical enterprise data. (Responsibility Units: Municipal Data Administration, Municipal Committee on Internet Information Affairs, Lingang New Area Management Committee)

Promote the international development of the industry.

Support foreign-funded enterprises to invest and develop in Shanghai. Support foreign-funded enterprises to establish regional headquarters, foreign-funded R&D centers, open innovation platforms, concept verification centers, and common technology platforms in Shanghai. Select qualified foreign-funded enterprises in the Shanghai FTZ (including Lingang New Area) to carry out gene diagnosis and treatment technology development and application expansion and opening-up pilots. Explore and promote the cross-border segmented production of biopharmaceuticals in Shanghai. (Responsibility Units: Municipal Commission of Commerce, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Health Commission, Municipal Drug Administration, Pudong New Area Government, Lingang New Area Management Committee)

Further improve the facilitation level of goods import and export. Optimize R&D used goods import pilot policies, improve the management model oriented by enterprise credit, expand the pilot scope to trace quantities of standards used for detection, and exempt from the import license and certificates issued by agricultural and environmental protection departments for qualified trace quantities of standard products for detection. Further expand the scope of identification of special goods for joint supervision of import and export special goods, and support the import and export of cell therapy products and related special goods. (Responsibility Units: Municipal Commission of Commerce, Municipal Science and Technology Commission, Shanghai Customs, Municipal Drug Administration)

Increase support for global registration and certification of innovative products. For innovative drugs, modern traditional chinese medicine, and high-end medical instruments developed by companies in our city, if they are registered through the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Community (CE), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), the World Health Organization, as well as regulatory agencies of BRICS and Belt and Road countries, and achieve local sales, they will be given support not exceeding 30% of R&D investment, up to a maximum of 10 million yuan. Encourage innovative companies to connect and cooperate with multinational enterprises. For overseas equity license transactions with a down payment of more than 100 million yuan (both parties should have no investment-related relationships), the transferor will be given support not exceeding 50% of its third-party professional service investment, up to a maximum of 5 million yuan. (Responsible Units: Municipal Science and Technology Commission, Municipal Business Committee, Municipal Finance Bureau)

Promote international academic and commercial exchanges in the field of medicine. Deepen the cooperation and exchange in the biopharmaceutical industry in the Shanghai-Hong Kong-Macao Greater Bay Area. Support the organization of biopharmaceutical-related conferences and academic exchanges, regulatory docking and other activities. For our city's enterprises or organizations participating in international activities and exhibitions, according to the regulations, they will be given support not exceeding 50% of the project funding, up to a maximum of 0.05 million yuan. The cumulative support amount for each unit shall not exceed 0.5 million yuan per year. (Responsible Units: Municipal Science and Technology Commission, Municipal Drug Administration, Municipal Finance Bureau)

The scope of support in these opinions is for enterprises, public institutions, or private non-enterprise units registered in our city and engaged in R&D, production, and professional services in the fields of pharmaceuticals, medical instruments, biotechnology, and life science research instruments. If there is overlap with other similar policies in our city, support will be given based on the principles of "优、高、不重复". Encourage each district to provide corresponding support according to the actual situation and strengthen the policy coordination between the municipal and district levels.

These opinions shall be implemented from August 1, 2024 to July 31, 2029. From June 1, 2024 to July 31, 2024, policies and measures related to funding support will be implemented according to these opinions.

Shanghai Municipal People's Government Office

July 15, 2024

This article is selected from the official website of the Shanghai Municipal People's Government, edited by Zhidao Finance: Li Fo.